Lead I - CSV Validation Engineer

Requirements

Role description

• At least with 5 - 8 years of relevant validation experience
• Candidates must have working experience with system development life cycle and creation and approval of key validation documentation mentioned above.
• Candidates must have working experience with reviewing SDLC deliverables and providing feedbacks from a regulatory/validation perspective, pre and post execution review of test scripts, attending stand up calls, and following up with project team on outstanding issues or clarifications. Candidates must have ability to multi-task and be flexible in a fast paced environment.
• Candidates must have excellent communication (verbal and written), ability to multi-task and share ideas on improving efficiency while maintaining regulatory compliance.
• Candidates must be able to meet project deadlines.
• Must have Clinical/Pharma Industry experience with knowledge of regulatory expectations for computerized systems, 21 CFR Part 11, Annex 11, Data Integrity and Good Documentation Practices.
• Candidate must be able to work in the UK work shift and must be office-based at least 60% of time.

Skills software engineering,regulatory domain,regulatory compliance,pharmaceutical,